JP6537517B2 - 多電極神経ペーシングの最適化のためのシステムおよび関連する方法 - Google Patents
多電極神経ペーシングの最適化のためのシステムおよび関連する方法 Download PDFInfo
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- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36128—Control systems
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- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
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- A—HUMAN NECESSITIES
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
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- A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
- A61B5/024—Detecting, measuring or recording pulse rate or heart rate
- A61B5/0245—Detecting, measuring or recording pulse rate or heart rate by using sensing means generating electric signals, i.e. ECG signals
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- A61B5/25—Bioelectric electrodes therefor
- A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
- A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
- A61B5/283—Invasive
- A61B5/287—Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
- G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
Description
・脊髄または脳幹に影響を与える恒久的または一時的な損傷または疾患、
・筋萎縮性側索硬化症(Amyotrophic Lateral Sclerosis:ALS)、
・日中または夜間の換気駆動の低下(例えば中枢性睡眠時無呼吸、オンディーヌの呪い(先天性中枢性肺胞低換気症候群))、
・麻酔剤および/または機械的換気の影響下における換気駆動の低下、
が挙げられる。これらの健康状態は相当数の人々に影響を与えている。
・肺水腫および感染症(人工呼吸器関連肺炎、ventilator−associated pneumonia:VAP)に対する感染性の増大につながり得る人工呼吸器誘発性肺損傷(ventilator−induced lung injury:VILI)および肺胞損傷をしばしば引き起こし、
・一般に、急性的に挿管された患者の不快感および不安を低減するために鎮静を必要とし、
・使われていない横隔膜筋の急速な退化(人工呼吸器誘発性横隔膜機能不全、ventilator−induced diaphragm dysfunction:VIDD)を引き起こし、
・肺は加圧され、横隔膜は無活動であるため、静脈還流に悪影響を与える可能性があり、
・食事および会話を妨げ、
・容易に携行できない装置を必要とし、
・患者が正常な呼吸を回復できず、人工呼吸器依存になった場合には、院内で死亡する危険性を増大させる。
この開示において、数ある実施形態の中でも特に、神経ペーシング処置中に用いられる電極の組み合わせを選択するためのシステムおよび関連する方法について記載する。
電極の神経への近接性に加えて、神経に対する電極配置は、神経軸索を刺激するために必要とされる電流の量を低減し得る要因である。理論上および実際上、電極および電流の流れの方向が(図4Aおよび図4Bに示すように)神経に平行な場合には、神経軸索はより低い活性化電流を必要とし、よって活動電位を発生させるのに十分な大きさの長手方向の経膜脱分極(longitudinal transmembrane depolarization)を生じる。神経が走っている方向は正確には分からないことがあり、また個人毎に変化し得るので、神経刺激の間に最適な電極が選択されることを保証するために、様々な電極の組み合わせを試験することができる。図3の実施形態は、電極の2つの平行な列を含み、それらの列の中からカテーテルおよび神経に対して様々な配向を有する対を選択することができる。
図5を参照すると、神経刺激に対する横隔膜の反応を特徴付けるためにリクルートメント曲線またはシグモイド曲線(sigmoidals)が用いられている。リクルートメント曲線は、特定の電極の組み合わせによって神経を複数回刺激し(例えば図7〜図9に示すもののような多数の電気パルス76を送達し)、横隔膜の反応を測定し、その横隔膜の反応のモデルを構築するために最良適合線を調製することによって作成される。よって、リクルートメント曲線は、各刺激部位および電極の組み合わせに対して特有である。
図11〜図14Cを参照して、神経刺激のための最適な電極の組み合わせを判定するために複数の電極の組み合わせを試験するプロセスの例示的な実施形態を説明する。試験される各電極の組み合わせについて、電気パルス76が上述したように神経に送達され、横隔膜ペーシングシステムは、その特定の電極の組み合わせおよびその標的神経に対する効果に対応するリクルートメント曲線を作成することができる。
図14Aおよび図11に示すようなマッピングプロセスの第1段階では、長尺体4上に分散された、事前設定された電極の組み合わせに刺激が送達される。この段階において、1つの目的は、標的神経の解剖学的により近くに位置するカテーテルの局所を特定することにある。一実施形態において、事前設定された電極の組み合わせの初期のセットは、カテーテルの長さに沿ったすべての可能な電極の組み合わせを含まない。標的神経に近い可能性のある電極の組み合わせは、関連する活性化閾値またはリクルートメント曲線を必ずしも考慮することなく、刺激のランプ全体に対するそれらの反応の総計を比較することにより特定される。望ましくない生理的効果の発現を生じる電極の組み合わせはこの段階の間に排除される。
Claims (11)
- 横隔膜ペーシングシステムであって、
複数の電極を備えた電極アセンブリと、
電気刺激に対する患者の反応を監視するように構成された少なくとも1つのセンサーと、
刺激制御ユニットと、を備え、前記刺激制御ユニットは、
第1の複数の電極の組み合わせの各々によって、一連の第1電気刺激を神経に1つずつ送達し、
前記一連の第1電気刺激に対する第1患者反応を示す、少なくとも1つのセンサーからの入力を受信し、
前記第1の複数の電極の組み合わせのうちの第1サブセットであって、前記第1サブセットが前記神経に近接していることを示す第1患者反応に基づいて、該第1サブセットを選択し、
前記第1の複数の電極の組み合わせのうちの第1サブセット内の前記電極に基づいて、第2の複数の電極の組み合わせを決定し、
前記第2の複数の電極の組み合わせの各々によって、一連の第2電気刺激を前記神経に一つずつ送達し、
前記一連の第2電気刺激に対する第2患者反応を示す、少なくとも1つのセンサーからの入力を受信し、
前記第2患者反応に基づいて、前記第2の複数の電極の組み合わせのうちの第2サブセットを選択するように構成されており、前記第2サブセットは、前記第2の複数の電極の組み合わせのうちの他の電極より大きな第2患者反応を有する電極の組み合わせを含む、横隔膜ペーシングシステム。 - 前記電極アセンブリは、患者の静脈系内へ挿入するために構成されたカテーテルである、請求項1に記載のシステム。
- 前記患者の反応は、空気流量、容量および圧力のうちの少なくとも1つである、請求項1に記載のシステム。
- 前記患者の反応は、筋電図活動、中心静脈圧、心拍数、胸壁加速度、血中酸素飽和度、二酸化炭素濃度、カテーテル位置、機械的運動および抵抗のうちの少なくとも1つである、請求項1に記載のシステム。
- 前記第1電気刺激および第2電気刺激の各々は複数の電気パルスを含み、前記刺激制御ユニットはさらに、人工呼吸器から呼吸支援を受けている患者の呼吸終末期中に複数の電気パルスを送達するように構成されている、請求項1に記載のシステム。
- 前記患者の反応は、電気刺激に対する横隔膜反応を示している、請求項1に記載のシステム。
- 前記刺激制御ユニットは、前記第2サブセットが前記第2の複数の電極の組み合わせのうちの他の電極よりも低い活性化閾値を有する電極の組み合わせを含むように、該第2サブセットを選択するように構成されている、請求項1に記載のシステム。
- 前記刺激制御ユニットは、前記第1の複数の電極の組み合わせまたは第2の複数の電極の組み合わせのうちの電極の組み合わせに対して、その電極の組み合わせに対応する活性化閾値が前記第1の複数の電極の組み合わせまたは第2の複数の電極の組み合わせのうちの別の電極の組み合わせに対応する活性化閾値よりも高いという判定に基づいて、電気刺激の送達を中止するように構成されている、請求項1に記載のシステム。
- 前記刺激制御ユニットは、前記第1電気刺激および第2電気刺激のうちの一方の電流のパルス幅および振幅を調節するように構成されている、請求項1に記載のシステム。
- 前記刺激制御ユニットは、前記第1電気刺激および第2電気刺激のうちの一方に対する患者の反応が神経の最大上動員を示す場合には、その第1電気刺激および第2電気刺激のうちの一方の電流の振幅を調節するように構成されている、請求項1に記載のシステム。
- 前記少なくとも1つのセンサーは2つ以上のセンサーを含む、請求項1に記載のシステム。
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PCT/CA2015/050035 WO2015109401A1 (en) | 2014-01-21 | 2015-01-20 | Systems and related methods for optimization of multi-electrode nerve pacing |
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CA2676119C (en) | 2007-01-29 | 2021-01-19 | Simon Fraser University | Transvascular nerve stimulation apparatus and methods |
CN107126622A (zh) | 2012-03-05 | 2017-09-05 | 西蒙·弗雷瑟大学 | 神经刺激系统 |
EP2863987B1 (en) | 2012-06-21 | 2023-08-02 | Lungpacer Medical Inc. | Transvascular diaphragm pacing systems |
US9242088B2 (en) | 2013-11-22 | 2016-01-26 | Simon Fraser University | Apparatus and methods for assisted breathing by transvascular nerve stimulation |
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